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Standard Operating Procedures (SOPs)
At Iowa State University, the Institutional Review Board (IRB) reviews all research involving human subjects, including proposals to gather data from subjects for theses, dissertations, and other student projects. The committee has representatives from various areas within the university and includes a member from the community. The community member is asked to disclose any conflict of interest they may have with Iowa State University and that information will be kept in their file.
The IRB Committee has the authority to approve, require modifications or disapprove all human subject research activities at Iowa State University.
The full board review process is as follows. The Chair, designee, or any IRB member can set up a meeting. The IRB Committee meets twice per month. A copy of each protocol to be reviewed is sent or delivered to the committee members for review before the scheduled meeting. The Administrator records the minutes of the meeting. Included in the minutes is the attendance, date, actions taken by the board, and the vote on actions taken.
Expectations and responsibilities of the IRB members are to attend each meeting; to be prepared to discuss each protocol and other agenda items; to use all of one's area of expertise; to maintain confidentiality regarding any information contained in any review; to reveal any potential conflict of interest as soon as it arises; and to be familiar with the SOP and forms.
The IRB Committee will review protocols that have more than minimal risk. Following is the definition of minimal risk as defined in 45 CFR 46:
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
If an IRB member is an investigator on a protocol that is being reviewed by the Committee, they may be present to address any questions, and then the member is excused for the deliberation and vote by the remaining IRB members.